Cleared Traditional

AnemoCheck Home

K221508 · Sanguina, Inc. · Hematology

Sep 2023

Decision

493d

Days

Class 2

Risk

About This 510(k) Submission

K221508 is an FDA 510(k) clearance for the AnemoCheck Home, a Whole Blood Hemoglobin Determination (Class II — Special Controls, product code KHG), submitted by Sanguina, Inc. (Peachtree Corners, US). The FDA issued a Cleared decision on September 29, 2023, 493 days after receiving the submission on May 24, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number	K221508 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2022
Decision Date	September 29, 2023
Days to Decision	493 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF